{"analyses":[{"ciLowerLimit":"0.85","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.44","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.80","pValueComment":"One-sided significance level = 0.05","paramType":"Hazard Ratio (HR)","paramValue":"1.11","statisticalMethod":"Gray's test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"21.1","upperLimit":"30.1","value":"25.6"},{"groupId":"OG001","lowerLimit":"23.6","upperLimit":"32.9","value":"28.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"360"}],"units":"Participants"}],"description":"Local-regional failure time is defined as time from randomization to relapse/progression in the primary tumor or regional nodes (event), death due to study cancer or unknown causes (event), death due to other causes (competing event), distant metastasis (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.","dispersionType":"95% Confidence Interval","groups":[{"description":"Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.","id":"OG000","title":"Standard Fractionation RT + Cisplatin"},{"description":"Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.","id":"OG001","title":"Accelerated Fractionation RT + Cisplatin"}],"paramType":"NUMBER","populationDescription":"Eligible patients who did not withdraw consent","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.","title":"Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]","type":"SECONDARY","unitOfMeasure":"percentage of participants"}